J&J to call for voluntary return of morcellators

JonKamp

Johnson & Johnson, which already suspended sales of a surgical tool that has been blamed for spreading a dangerous cancer in women, now plans to tell doctors world-wide to return any devices currently on shelves.

The move amounts to an effective recall for the device called a laparoscopic power morcellator. J&J halted sales of new morcellators in April after the U.S. Food and Drug Administration advised doctors not to use the tool, which slices up uterine masses called fibroids, and uteruses themselves, into fragments so they can be removed in minimally invasive surgery.

At the time, J&J defended the safety of the tool, but said it was waiting for a definitive decision from the FDA.

The FDA hasn't issued a permanent decision on the morcellator's future. But J&J's Ethicon subsidiary plans to inform customers in a letter Thursday that it is initiating a voluntary market withdrawal because it is not clear that the benefits of the device outweigh its risks. This isn't an official recall because the action isn't related to how the product performs, a company spokesman said.

In a letter reviewed by The Wall Street Journal, Ethicon said that an FDA hearing on the device held earlier this month "demonstrated the complexity of the issue." Uterine cancers, called sarcomas, can masquerade as benign fibroids and can't be reliably detected before surgery. Using a morcellator can inadvertently spread malignancies and other diseased tissues inside the body, possible worsening outcomes.

"Because of this uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk," the company said.

Gynecologists told The Wall Street Journal Wednesday that representatives for the company's Ethicon division told them J&J will exit the morcellator market. Christopher Stanley, the medical director of female pelvic medicine and reconstructive surgery at Halifax Health Medical Center in Daytona Beach, Fla., said he received a text Wednesday from an Ethicon representative. "J& J is going to officially withdraw from the morcellation business," Dr. Stanley said he was told.

David Mutch, the chief of gynecologic oncology at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, said his hospital had received the same alert.

A J&J spokesman said, "No decision has been made at this time with regard to our future involvement in the market."

The company doesn't disclose morcellator sales, but they are a very small part of the health-care conglomerate's overall business, which posted sales of $71.3 billion in 2013.

But the company is by far the biggest manufacturer in the market for laparoscopic morcellators. In 2011, the company held an estimated 72% of the market for these devices, according to the most recent data provided by iData Research Inc., a market research firm.

Smaller manufacturers, including German companies Karl Storz GmbH and Richard Wolf GmbH, have declined to discuss the morcellator debate and their market plans. Olympus Corp. which makes a morcellator that cuts with electricity rather than a blade, declined to comment on plans for its device. LiNA Medical, a privately held Danish company that makes morcellators, hasn't responded to requests for comment.

The FDA has estimated the tool was used in 50,000 hysterectomies a year. They were also commonly used for removing fibroids alone.

In April, the FDA said women undergoing surgery for fibroids have a one-in-350 risk that the growths are actually cancerous tumors that can't be reliably detected before surgery. The agency said morcellators, which typically use a fast-spinning blade, can spread the cancer and significantly worsen a patient's odds of long-term survival, the agency said. The risk of cancer previously had been believed to be far lower.

Last week, a new study by Columbia University found a similar risk: one in 368 women undergoing hysterectomies have a hidden uterine cancer that could be spread by a morcellator. The report in the Journal of the American Medical Association was the largest assessment yet of the device's risk and examined the records of a much larger group of women than the FDA did in its main analysis. The study also concluded that the surgical device has the potential to spread more types of uterine cancer in a woman's body than previously thought.

Major gynecology groups have defended the device as an important tool that helps women avoid open surgery, which can have more complications, such as blood loss, and lead to longer recoveries.

Some gynecologists who are advisers to J& J supported the move. "The bottom line is that it looks like the sarcoma risk is much higher than we originally thought," said Steven McCarus, an Ethicon consultant, and the chief of gynecological surgery for Florida Hospital Celebration Health near Orlando.

Dr. McCarus said he was one of several doctors who recently sat on a committee formed by the company to review the literature on power morcellators and the cancer-spreading risk. Dr. McCarus said he advised Ethicon that the risk was too high.

"I support it 100%. They are putting patients before risk and technology, " he said of the company's decision. "The real issue is, will other companies follow and if they don't, why not?"

Write to Jon Kamp at jon.kamp@wsj.com and Jennifer Levitz at jennifer.levitz@wsj.com

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